Urinary catheter and method with increased resistance to obstructions

ABSTRACT

A catheter for draining urine from a bladder is made more resistant obstructions and blood clot accumulations by configurations of urine inlet openings into an interior urine drainage passageway. The inlet opening configurations include a whistle tip, a multiple opening tip, a couvelaire tip, and a beveled tip with a direct opening into the passageway. A low friction coating also resists blood clot accumulation. A single-use or multiple-use clearing device moves within the interior drainage passageway to contact, disintegrate, and facilitate movement of the accumulated clots and obstructions out of the urine inlet opening and interior passageway.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a continuation in part of U.S. application Ser. No. 10/665,742,filed Sep. 17, 2003, by the inventors hereof and assigned to theassignee hereof. The subject matter of this prior application andinvention is incorporated herein by this reference.

FIELD OF THE INVENTION

This invention relates to an urinary catheter and the use of an urinarycatheter. More particularly, the present invention relates to a new andimproved catheter that reduces the incidence of obstructions in theurine flow path through the catheter, such as those arising from bloodclots, and to a new and improved catheter that facilitates removing anddisintegrating blood clot obstructions should they occur.

BACKGROUND OF THE INVENTION

Prostate problems, such as benign prostate hyperplasia (BPH) andmalignant prostate cancer, are common occurrences among older men. Theeffects of these diseases are generally accompanied by swelling orenlargement of the prostate gland. Apart from the life-threateningaspects of malignant prostate cancer, the everyday symptoms and effectsof these diseases are usually troublesome. One such problem relates tothe ability to control and achieve normal urine discharge. When theprostate gland enlarges to the extent that it obstructs the prostaticurethra through the prostate gland, considerable difficulties arise indischarging urine at will. Such difficulties are typically referred toas urinary tract retention. Urinary tract retention can be either acuteor chronic.

Surgical treatments are available for relieving urinary tract retentionproblems, e.g. transurethral resection of the prostate (TURP). A TURPprocedure involves surgically resecting tissue from the prostate glandto eliminate or reduce obstruction or restriction. Surgical operationsoffer a high probability of an excellent clinical outcome, but they areassociated with a high degree of morbidity. Alternative treatments withmilder side-effects include transurethral microwave thermotherapy(TUMT), radio frequency needle ablation (TUNA), interstitial laser andhot water induced thermotherapy (WIT). All of these alternativetreatments involve heating the obstructive prostatic tissue until thetissue is destroyed or damaged. Thereafter, the destroyed or damagedtissue sloughs off, is absorbed in the body, and otherwise results in anenlargement of the urinary passageway through the prostate gland. Theenlargement of the urinary passageway through the prostate glandeliminates or relieves the obstruction and permits better urine flow. ATURP procedure involves surgically resecting tissue from the prostategland to eliminate or relieve the obstruction.

TURP and the different prostate heat treating techniques cause temporaryside effects, for example inflammation and swelling of the prostate. Theside effects usually require the patient to use an indwelling urinedrainage catheter for a few days up to several weeks following theprocedure to permit urination while the swelling subsides and the tissueof the prostate gland heals or stabilizes. The tissue of the prostategland which remains viable after a TUMT or a heat treatment is quite rawand tender, and direct contact from urine can aggravate the inflammationand increase the risk of infection. An indwelling catheter permits theurine to pass through the tissue where the surgical procedure wasperformed with minimal or no contact with the treated tissue.

In those cases where the diseased prostate gland cannot be treated by aTURP or a heat treatment, the obstruction may become so significant thatnormal urinary functions are not possible or are only possible withgreat difficulty. In these circumstances, it is necessary for a catheterto be used for the rest of the patient's life. In some cases, thepatient is taught to insert a full-length catheter whenever urination isnecessary. In other cases where the patient cannot insert a full-lengthcatheter himself, medical personnel insert the full-length catheter inthe urinary tract where it remains until removal by medical personnel.

The typical type of urinary catheter used while the prostate glandheals, or on a continual basis, is a full-length urinary catheter. Afull-length urinary catheter extends from the exterior opening of theurinary canal through the entire length of the urinary tract into thebladder. A clamp or other mechanical valve at the exterior of thecatheter is opened to drain the urine from the bladder and is closed toterminate urination. A reservoir may be attached to the end of thecatheter to collect the urine discharge, in which case the mechanicalvalve and clamp may not be used. The internal urinary sphincter muscleat the bladder neck, which normally controls the flow of urine from thebladder into the prostatic urethra and the remainder of the urinarycanal, is no longer able to perform its natural function of constrictingthe urethra to stop urine flow and dilating to allow urine flow. TURPand heat treatment surgical procedures usually destroy the internalurinary sphincter muscle. Even if not destroyed, neither the internalurinary sphincter muscle, which is located upstream of the prostaticurethra, nor the external urinary sphincter muscle, which is locateddownstream of the prostatic urethra, can control urine flow because acontinuously open urine flow passageway extends through the catheter andthese urinary sphincter muscles which cannot close the passagewaythrough the catheter.

In addition to the patient lacking the ability to naturally controlurine flow when using a full-length urinary catheter, the extension ofthe catheter out of the exterior opening of the urinary canal and thepresence of the clamp valve and the reservoir cause discomfort, areawkward to deal with and may be embarrassing for the patient. Thefull-length urinary catheter may create limitations from a socialstandpoint and almost always creates quality of life issues which mustbe confronted. Sexual activity is impossible. An increased risk ofinfection also results.

Because of the quality of life and social issues associated withfull-length urinary catheters, partial-length indwelling catheters havebeen developed. Partial-length indwelling catheters typically extendonly from the bladder through the prostatic urethra, and not along theentire length of the urinary tract from the bladder to the exterioropening. The reduced length permits the external urinary sphinctermuscle to control urine flow in a more natural manner, while stillbypassing most of the urine flow around the swollen or raw prostategland. No sizeable part of the catheter extends out of the exterioropening of the urinary canal.

Keeping a partial-length indwelling catheter in the proper position isessential. The short length may allow the catheter to move completelyinto the bladder or move out of the prostatic urethra into the urinarycanal. Either type of unintended movement may require serious medicalintervention to correct.

A partial-length urinary catheter typically uses an inflatable balloonor other form of anchor at its end which is innermost within the bodyand upstream relative to the urine flow. The balloon is expanded, or theanchor is enlarged, within the bladder, and the catheter is then iswithdrawn until the balloon or anchor contacts the bladder neck at theentrance to the urethra. The balloon or anchor prevents the catheterfrom moving out of the bladder and into the urinary canal. However, theballoon cannot prevent the partial-length urinary catheter from movingout of the prostatic urethra and into the bladder.

One way of preventing a partial-length urinary catheter from moving intothe bladder involves attaching a downstream anchor to the partial-lengthof catheter with a short length of thread-like material. The thread-likematerial extends through the orifice of the external urinary sphinctermuscle, and the downstream anchor is positioned downstream from theexternal urinary sphincter muscle. The catheter and the anchor tube arepositioned in the prostatic urethra and the urinary canal, respectively,on opposite sides of the external urinary sphincter muscle. The externalurinary sphincter muscle is able to constrict around the thread-likematerial to stop urine flow and is able to dilate to permit the flow ofurine. The normal constricted state of the external urinary sphinctermuscle adjacent to the anchor tube prevents the partial-length catheterfrom moving into the bladder.

Treatment of the prostate gland with a TUMT or a heat treatment usuallycauses the destruction of the bladder neck and results in blood clotswhich enter the bladder. These clots float in the urine in the bladderand enter the catheter where they can accumulate to the extent ofobstructing the flow of urine through the catheter. If the patient isunable to clear the clot accumulation by urinating, then the cathetermust be medically removed and replaced. Replacement of the cathetershortly after treatment causes irritation to the treatment area, can bepainful for the patient, typically prolongs of the healing time period,and creates greater medical expense if the catheter must be removed andreplaced. The problems of possible obstructions from blood clots areequally applicable to full-length and partial-length catheters.

Another possibility of blockage of the catheter is due to obstructionsfrom other natural body substances in the bladder or the urine. Whilesuch risks are not as significant as those risks which arise because ofblood clots after a surgical procedure, such risks are neverthelesssignificant for those individuals who must utilize an urinary catheteron a full-time basis, because of the continual possibility ofobstruction to the urine passageway through the catheter.

SUMMARY OF THE INVENTION

In general, the present invention pertains to a full-length orpartial-length urinary catheter which extends from the bladder throughthe urinary tract to the exterior opening of the urinary canal. Thecatheter resists the accumulation of blood clots and obstructions withinan interior urine drainage passageway of the catheter, therebymaintaining the urine drainage capability of the passageway through thecatheter. The catheter is beneficial in avoiding entirely or reducingthe number of instances where a medical or surgical procedure isrequired to remove and replace the entire catheter. The catheter alsopromotes better healing of the prostate gland after surgery because ofthe continually open urine drainage passageway which conducts the urineaway from the surgically-affected area and thereby reduces the risk ofinfection and irritation.

These and other improvements and advantages are achieved by a catheterused to drain urine from a bladder to a location adjacent to an externalurinary sphincter muscle of an urinary tract. The urinary tract includesan urinary canal extending from the external urinary sphincter muscle toan exterior opening of the urinary canal. An inlet opening is located inthe distal end of the catheter and has a configuration which facilitatespassing urine and blood clots from the bladder into an interior urinedrainage passageway of the catheter. The configuration of the inletopening reduces blood clot accumulation and other urine flowobstructions.

The inlet opening may assume different beneficial alternativeconfigurations. The urinary opening may be defined by the absence of alongitudinal half portion of a rounded tip and a distal end portion ofthe catheter adjacent to the rounded tip established by longitudinallybisecting the rounded tip. The longitudinal half portion is establishedby longitudinally bisecting the rounded tip and the distal end portionadjoining the rounded tip. A whistle-tip shape results from thisconfiguration. The inlet opening may be defined by a plurality ofseparate openings, each of which is spaced from an adjacent separateopening along the distal end portion adjacent to the rounded tip. Eachof the separate openings communicates with the interior urine drainagepassageway in the catheter. The inlet opening may be defined by tworadially opposite openings having a transverse dimension greater thanone fourth of the circumferential distance around the main body and across-sectional size substantially greater than the cross-sectional sizeof the interior passageway of the catheter. A couvelaire tip resultsfrom this configuration. The inlet opening may be defined by asubstantially direct opening through a beveled tip of the catheter. Thedirect opening substantially aligns with the interior passageway of themain body and has a cross-sectional size at least equal to thecross-sectional size of the interior passageway. In addition to theinlet opening configurations, the catheter may include a low frictioncoating over the distal end, within the inlet opening, and along theinterior passageway, to resist the attachment and the accumulation ofblood clots and other obstructions.

The catheter may also incorporate a clearing device within the internalurine drainage passageway of the catheter. The clearing device includesa contact element normally located in a stowed position at a distal endof the interior passageway. The contact element moves within theinterior passageway from the stowed position past the inlet opening andalong the interior passageway to a position downstream of the inletopening in the urine flow path through the catheter. The movement of thecontact element into contact with blood clots or other obstructions inthe inlet opening and in the interior passageway disintegrates the bloodclot accumulations and obstructions and facilitates passage of the clotsand obstructions through the catheter with urine flow. Preferably, anactivation device is connected to the contact element, and theactivation device extends through the urinary canal to a positionoutside of the exterior opening of the urinary canal. Manipulation ofthe activation device at the position outside of the exterior opening ofthe urinary canal moves the contact element to disintegrate the bloodclot accumulations and other obstructions and facilitates passage of theclots and obstructions through the interior passageway with the urine.

A more complete appreciation of the scope of the present invention andthe manner in which it achieves the above-noted and other improvementscan be obtained by reference to the following detailed description ofpresently preferred embodiments taken in connection with theaccompanying drawings, which are briefly summarized below, and byreference to the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an indwelling prostatic catheter whichincorporates the present invention, shown attached to an insertion tooland used with a syringe.

FIG. 2 is an enlarged perspective view of the indwelling prostaticcatheter shown in FIG. 1 with the insertion tool removed and with aballoon of the indwelling catheter expanded.

FIG. 3 is an enlarged longitudinal cross-section view takensubstantially in a longitudinal axial plane through FIG. 2.

FIG. 4 is an enlarged transverse cross-section view taken substantiallyin the plane of line 4-4 of FIG. 1.

FIG. 5 is an enlarged partial longitudinal axial cross-section view of aseparable connection of the indwelling catheter-insertion tool assemblyshown in FIG. 1, taken substantially in the plane of line 5-5 shown ofFIG. 1.

FIG. 6 is a perspective view of the indwelling catheter and a portion ofthe insertion tool shown in FIG. 1, shown inserted within a urethra, aurethra sphincter, a prostatic urethra and a bladder of an urinary tractof a human being, with the physiology generally illustrated in crosssection.

FIG. 7 is an illustration similar to FIG. 6 showing the balloon inflatedwithin the bladder.

FIG. 8 is an illustration similar to FIGS. 6 and 7 showing separation ofthe insertion tool from the indwelling catheter.

FIG. 9 is an illustration similar to FIGS. 6-8 showing the position anduse of the indwelling catheter.

FIG. 10 is a partial, enlarged and broken view of the catheter-insertiontool assembly shown in FIG. 1, illustrating an alternative embodiment ofthe separable connection shown in FIG. 5, and other aspects of theinvention.

FIG. 11 is a perspective view of an indwelling catheter similar to thatshown in FIG. 2 with a different distal end configuration.

FIG. 12 is a perspective view of an indwelling catheter similar to thatshown in FIG. 11 with another distal end configuration.

FIG. 13 is a perspective view of an indwelling catheter similar to thatshown in FIGS. 11 and 12 with still another distal end configuration.

FIG. 14 is a perspective view of an indwelling catheter similar to thatshown in FIGS. 11-13 with a further distal end configuration.

FIG. 15 is a cross-section view of an indwelling catheter similar tothat shown in FIG. 3 which further includes an obstruction clearingdevice located in a stowed position.

FIG. 16 is a cross-section view similar to that shown in FIG. 15,showing the clearing device moved longitudinally within an interiorpassageway of the catheter from the position shown in FIG. 15 to anoperative position which clears obstructions.

DETAILED DESCRIPTION

A partial-length indwelling catheter 20 which incorporates the presentinvention is shown in FIG. 1, but the present invention is alsoapplicable to full-length catheters (not shown). The indwelling catheter20 is connected to an insertion tool 22, to form a catheter-toolassembly 24, which allows the catheter 20 to be inserted into an urinarytract 26 of a human being, as shown in FIG. 6. Once inserted, theinsertion tool 22 is disconnected or separated from the indwellingcatheter 20 to leave the catheter 20 dwelling or remaining within aprostatic urethra 28 within a prostate gland 30, as shown in FIG. 9. Inits indwelling use position shown in FIGS. 8 and 9, the catheter 20drains urine from a bladder 32 through the prostatic urethra 28 withinthe prostate gland 30 to a position slightly upstream of an externalurinary sphincter muscle 34. When the external urinary sphincter muscle34 dilates, the urine drains through an orifice of the the externalurinary sphincter muscle 34 and into an urinary canal 36 of the urinarytract 26.

The catheter 20 will typically be left in the indwelling position shownin FIG. 9 for a number of days or weeks to function as a temporary stentto protect raw tissue of the prostate gland 30, after it has beenoperated on to remove portions of the prostatic urethra 28 and thesurrounding tissue of the prostate gland 30 in a transurethral resectionof the prostate (TURP) surgical procedure, or after these tissues havebeen destroyed or operated on by a microwave thermotherapy treatment(TUMT) or other thermotherapy treatment. In addition, the catheter 20can also be used as a stent through the prostatic urethra 28 when it hasbeen constricted to the point where urine will no longer passeffectively as a result of swelling in the prostate gland 30 due tobenign prostate hyperplasia (BPH) or other obstructions orabnormalities. There are other medically-recognized reasons to use theindwelling catheter 20.

The indwelling catheter 20 is positioned as shown in FIG. 9 by pushingthe catheter 20 into the urinary tract 26 with the insertion tool 22until a distal end 38 of the indwelling catheter 20 enters the bladder32 as shown in FIG. 6. A balloon 40 on the indwelling catheter 20 isinflated with fluid conducted through an inflation passageway 42 of aninflation tube 44 (FIG. 3) until the balloon 40 is larger in diameterthan a neck 46 of the bladder 32 surrounding the prostatic urethra 28.The inflation fluid may be gas, such as air, or liquid such as salinesolution. The balloon 40 is preferably inflated from an inflation pumpsuch as a syringe 48 which is connected to a valve assembly 50 at theend of the inflation tube 44 (FIG. 1). Once the balloon 40 has beeninflated, the insertion tool 22 is pulled backward until the inflatedballoon 40 is seated on the bladder neck 46, as shown in FIG. 7. Whenseated on the bladder neck 46, the balloon 40 prevents the indwellingcatheter 20 from moving out of the bladder 32, through the externalurinary sphincter muscle 34 and into the urinary canal 36.

Continued withdrawal movement of the insertion tool 22 causes it toseparate from the catheter 20 at a separable connection 52 (FIG. 1)between the indwelling catheter 20 and the insertion tool 22 as shown inFIG. 8, thereby leaving the indwelling catheter 20 in its final,indwelling position shown in FIG. 9. The insertion tool 22 is thereafterwithdrawn and removed from within the urinary canal 36. The inflationtube 44 remains within the urinary canal 36.

The relative terms “proximal” and “distal” are used in this descriptionin relation to the medical practitioner who inserts the catheter 20 intothe urinary tract 26 at the exterior opening of the urinary canal 36.Accordingly, the portions of the catheter 20 which are the most internalwithin the patient are referred to as “distal,” and the portions of thecatheter 20 which are closest to the exterior opening of the urinarycanal 36 are referred to as “proximal.” The distal portions of thecatheter are therefore located more interiorly within the urinary tract26 than are the proximal portions of the catheter. The distal portionsof the catheter are upstream relative to the normal direction of urineflow, and the proximal portions of the catheter are downstream relativeto the normal direction of urine flow. The balloon 40 is located nearthe distal end of the catheter 20, and a distal end of the inflationtube 44 connects to a proximal end of a main body 58 of the catheter 20at a location upstream or distal of the external urinary sphinctermuscle 34.

The inflation tube 44 is formed with a permanently helically coiledsection 54 shown in FIGS. 1-3 and 6-9. The coiled section 54 isresilient both in the transverse dimension and in the longitudinaldimension. The inflation tube 44 has sufficient strength to maintain thecoiled section 54 in the coiled configuration within the urinary canal36 after removal of the insertion tool 22. Because of the resiliency ofthe coiled section 54, the coiled section 54 presses against theinterior of the urinary canal 36. The orifice through the externalsphincter 34 is normally closed except during urination thus preventingthe coiled section 54 from migrating distally or upstream past theexternal sphincter 34. In this way, the coiled section 54 resistsmovement along the urinary canal 36 to hold the indwelling catheter 20from moving along the urinary canal 36. By resiliently pressing againstthe interior of the urinary canal 36, the coiled section 54 alsominimizes discomfort to the patient or irritation to the urinary canal36. The coiled section 54 is not disruptive to the flow of urine throughthe urinary canal 36 because the coiled section 54 provides a fluid-flowpath through an open center of the coils.

With the catheter 20 connected to the insertion tool 22, the coiledsection 54 extends around the exterior of the insertion tool 22, asshown in FIG. 4. By extending around the exterior of the insertion tool22, the coiled section 54 assists in holding the inflation tube 44adjacent to the insertion tool 22 while the indwelling catheter 20 andthe insertion tool 22 are inserted in the urinary tract 26. The coiledsection 54 therefore assists in moving the inflation tube 44 into theurinary tract 26 along with the insertion tool 22. The helically coiledsection 54 is loosely wound around the insertion tool 22, therebyallowing the insertion tool 22 to be withdrawn through the center of thecoiled section 54 as the insertion tool 22 is disconnected from theindwelling catheter 20.

The coiled section 54 is located a short distance proximally from theproximal end of the main body of the indwelling catheter 20. The lengthof the inflation tube 44 between the proximal end of the indwellingcatheter 20 and the coiled section 54 is sufficient to locate the coiledsection 54 within the urinary canal 36 at a position slightly proximalof the urinary sphincter muscle 34, as shown in FIGS. 6-9.

Located slightly proximally of the urinary sphincter muscle 34, thecoiled section 54 of the inflation tube 44 functions as an anchor toassist in holding the indwelling catheter 20 in the urinary tract 26 inthe position shown in FIG. 9. The coiled section 54 prevents theindwelling catheter 20 from moving distally from the position shown inFIG. 9, as a result of the coils of the coiled section 54 contacting aconstriction in the urinary tract caused by constriction of thesphincter muscle 34. The coiled section 54 contacts the constriction toresist the distal movement of the indwelling catheter 20 and to preventit from moving into the bladder 32. The inflated balloon 40 creates arestriction at the distal end 38 of the indwelling catheter 20 toprevent it from moving proximally along the urinary tract 26 and out ofthe urinary canal 36. With the inflated balloon 40 located at the distalend of the indwelling catheter 20 and the anchoring coiled section 54located on the proximal side of the sphincter muscle 34, the indwellingcatheter 20 resists movement either into or out of the bladder 32 andout of the prostatic urethra. Instead, the indwelling catheter 20 ismaintained in the use position.

With the indwelling catheter 20 in the use position anchored by theballoon 40 and the coiled section 54, urine or other fluid from thebladder 32 is able to flow through an interior passageway 56 (FIG. 3) inthe indwelling catheter 20 and out of the proximal end of the catheter20 past the dilated urinary sphincter muscle 34 (FIG. 9). The externalurinary sphincter muscle 34 retains the capability to constrict or closearound the inflation tube 44 to stop the urine flow. The urine isdischarged into the urinary canal 36 in the normal manner. The finalindwelling use position of the catheter 20 permits normal control by theexternal urinary sphincter muscle 34 over urine flow.

More details concerning the structure of the indwelling catheter 20 areillustrated in FIGS. 1-5. The indwelling catheter 20 includes a main orcentral body 58, preferably made from silicone rubber. The main body 58has a generally cylindrical exterior shape. The main body 58 includes asidewall 60 which defines the passageway 56 through the main body 58. Anend piece 62 is either attached to or integral with the main body 58 atthe distal end 38 of the catheter 20. The end piece 62 has a tipconfiguration adapted to facilitate insertion of the catheter 20 and theinsertion tool 22 into the urinary tract 26. At least one and preferablya pair of urine inlet openings 64 are formed through the end piece 62.The openings 64 communicate between the exterior of the end piece 62 andthe passageway 56 of the main body 58. Urine from the bladder 32 flowsthrough the openings 64 and into and through the passageway 56 to theother proximal end of the main body 58.

The balloon 40 is formed by a flexible sleeve 66 of relatively thin,flexible, expandable, usually-transparent and non-porous material whichis attached with fluid-tight seals 68 and 70 around the exterior of themain body 36. A first fluid-tight seal 68 is located slightly proximallyof the distal end of the main body 58 where the end piece 62 isattached, and a second fluid-tight seal 70 is spaced proximally alongthe main body 58 from the first seal 68 by a distance approximatelyequal to the axial length of the flexible sleeve 66. The fluid-tightseals 68 and 70 are preferably formed by attaching the flexible sleeve66 to the main body 58 with an adhesive or by thermal welding.

The flexible sleeve 66 is positioned over the top of and extends axiallyon opposite sides of an opening 72 from the main body 58. Thefluid-tight seals 68 and 70 are located distally and proximally of theopening 72, respectively. Fluid is introduced into a volume 74 at theexterior of the main body 58 between the fluid-tight seals 68 and 70 andwithin the flexible sleeve 66, causing the flexible sleeve 66 to expandoutward and create the balloon 40.

An inflation conduit 76 communicates with the opening 72, as shown inFIG. 3. The inflation conduit 76 is formed within the sidewall 60 of themain body 58. A distal end of the inflation tube 44 is inserted into aproximal end of the inflation conduit 76, as shown in FIGS. 3 and 5. Thefluid is delivered from the syringe 48 (FIG. 1) into the inflationpassageway 42 of the inflation tube 44 and flows into the inflationconduit 76, out of the opening 72 and into the volume 74 beneath theflexible sleeve 66, causing the flexible sleeve 66 to expand into theform of the balloon 40.

Inserting the distal end of the inflation tube 44 into the inflationconduit 76, as shown in FIG. 5, allows the inflation tube 44 to bypassor go around the separable connection 52 between the indwelling catheter20 and the insertion tool 22. A strong fluid-tight bond is formed byattaching the inflation tube 44 into the inflation conduit 76 with anadhesive. The attachment maintains the inflation tube 44 connected tothe main body so that pulling on the inflation tube from the exterior ofthe urinary canal 36 will remove the catheter 20 from the urinary tract26 without the inflation tube 44 breaking away from the main body 58. Inthis regard the inflation tube 44 also serves as a tether for thecatheter 20. The separable connection 52 shown in FIG. 5 permits thecommunication between the inflation passageway 42 and the inflationconduit 76 to remain intact and fluid tight after the insertion tool 22has separated from the indwelling catheter 20 while the catheter 20remains positioned within the urinary tract. The continued integrity ofthe inflation passageway between the balloon 40 and the valve assembly50 allows the balloon 40 to be periodically reinflated while theindwelling catheter 20 is in use, if necessary. Periodic reinflation maybe necessary as a result of minute leaks in the balloon 40, the valveassembly 50 or the passageways connecting the balloon 40 and the valveassembly 50.

The inflation tube 44 has a length which extends from the main body 58of the indwelling catheter 20 through the urinary canal 36 to theoutside of the human body. The length of the inflation tube 44 issufficient to position the valve assembly 50 at the exterior of thehuman body. The inflation tube 44 has sufficient rigidity to prevent theinflation passageway 42 within the tube 44 from collapsing from contactwith the tissue of the urinary tract 26, but the rigidity is not sogreat as to prevent a moderate amount of flexibility in the inflationtube 44. The moderate flexibility of the inflation tube 44 allows it toextend through the typical curves of the urinary tract 26.

The valve assembly 50 is of a conventional construction and includes areceptacle 78 into which a nozzle 80 of the syringe 48 is inserted, asshown in FIG. 1. The valve assembly 50 also includes a conventionalinternal check valve (not shown) which closes the inflation passageway42 at the valve assembly 50 when the nozzle 80 is removed from thereceptacle 78. In this manner, fluid from within the balloon 40 isprevented from escaping through the inflation passageway 42 when thesyringe 48 is disconnected from the valve assembly 50, but the checkvalve permits fluid from the syringe 48 to inflate the balloon 40 when aplunger (not specifically shown) of the syringe 48 is depressed. Thus,the balloon 40 will remain inflated after the syringe 48 is disconnectedfrom the valve assembly 50. However, should the balloon 40 need to bereinflated or should additional fluid need to be added to expand theballoon 40 during use of the catheter, the syringe 48 is easilyconnected to the valve assembly 50 for doing so.

As an alternative to the use of the valve assembly 50, the inflationpassageway 42 can be sealed at a proximal end after the balloon 40 hasbeen inflated. For example, instead of using the valve assembly 50 toprevent fluid from escaping from the balloon, a knot may be tied or anobstruction formed (neither shown) in the proximal end of the inflationtube 44 at a location spaced proximally from the end of the penis at theexternal opening of the urinary canal. The knot or obstruction seals theinflation passageway 42 and prevents the fluid from escaping through thepassageway to maintain the balloon 40 inflated. The inflation tube 42 iscut at a position slightly proximally of the knot or obstruction. Inthis alternative configuration, the inflation tube 44 without the valveassembly 50 extends only a modest distance from the open end of theurinary canal 36. Greater comfort and convenience is promoted becausethere is no sizable apparatus to deal with, such as the valve assembly50 connected to the proximal end of the inflation tube 44. If theballoon 40 needs to be reinflated or have additional fluid added afterthe indwelling catheter 20 has been used for some time, the knot orobstruction can be cut from the end of the inflation tube 44 and asuitable connector attached to allow the syringe 48 to introduceadditional fluid. After suitable inflation, another knot can be tied oran obstruction formed in the remaining proximal portion of the inflationtube 40. Releasing the fluid through the inflation passageway 42collapses the balloon 40 and allows the catheter 20 to be pulled out ofthe urinary canal 36 by pulling on the inflation tube 44.

The insertion tool 22 is a flexible tubular structure and is generallyconfigured similar to the distal portion of a typical full-lengthurinary catheter. The insertion tool 22 is at least long enough toextend from outside of the body into the urinary canal 36 and prostaticurethra 28 to a point that will place the indwelling catheter 20 in thefinal desired use position. The insertion tool 22 is preferably madefrom silicone rubber, but has sufficient structural integrity totransfer pushing forces supplied from the outside of the bodylongitudinally along the length of the insertion tool 22, therebyallowing the insertion tool 22 with the attached indwelling catheter 20to be moved distally into the urinary tract 26. A proximal end of theinsertion tool 22 may take the form of a hollow handle 82 orenlargement, by which to grip the insertion tool 22 and apply pushingforce to it during insertion in the urinary tract 26.

The separable connection 52 between the insertion tool 22 and theindwelling catheter 20 includes a sleeve 84, shown in FIG. 5. The sleeve84 is rigidly connected to the distal end of the insertion tool 22 by anadhesive, for example. A distal portion of the sleeve 84 projects beyondthe distal end of the insertion tool 22 and into the interior passageway56 of the catheter. The distal portion of the sleeve 84 has an exteriordiameter which frictionally fits within the interior passageway 56, andthe friction created by the insertion of the sleeve 84 into the interiorpassageway 56 is sufficient to retain the indwelling catheter 20 to theinsertion tool 22 during manipulation of the catheter-tool assembly 24within the urinary tract 26 during insertion and placement, prior toinflation of the balloon 40. However, the degree of frictionalresistance between the distal end of the sleeve 84 and the main body 58at the proximal end of the interior passageway 56 is not so great as toprevent the indwelling catheter 20 from separating from the insertiontool 22 once the balloon 40 has been inflated and seated against thebladder neck 46. The amount of frictional resistance between the distalportion of the sleeve 84 and the proximal end of the main body 58 at theproximal end of the interior passageway 56 can be increased by formingserrations on the exterior of the distal end of the sleeve 84. Theresilient material of the main body 58 will deform slightly around theserrations to further assist in holding the indwelling catheter 20 tothe insertion tool 22, but the amount of deformation is not so great asto prevent separation of the indwelling catheter 20 and the insertiontool 22 at the separable connection 52. The sleeve 84 has a centeropening 86 formed through it to provide a fluid flow path from thepassageway 56 through the sleeve 84.

The catheter-tool assembly 24 is inserted and used in the mannerillustrated in FIGS. 6-9. As shown in FIG. 6, the catheter 20 and theinsertion tool 22 are inserted into the urinary tract 26 through theurinary canal 36, in a manner similar to the way that a conventionalfull-length urinary catheter would be inserted. The insertion force isapplied by pushing on the insertion tool 22 and on the handle 82attached at its proximal end. Distal movement of the catheter-toolassembly 24 continues until the rounded end piece 62 and a significantdistal portion of the indwelling catheter 20 are located in the bladder32. The insertion is sufficient to assure that the flexible sleeve 66will be located within the bladder 32. To assure sufficient insertion,it is frequently the case that the distal movement continues untilterminated when the end 38 contacts the opposite wall of the bladder 32,thereby assuring that the balloon 40 is within the bladder 32. Duringinsertion in this manner, the coiled section 54, which is wrapped aroundthe insertion tool 22, helps keep the forward or distal portion of theinflation tube 44 aligned with and progressing with the indwellingcatheter 20.

Once the catheter-tool assembly 24 has been inserted sufficiently, theballoon 40 is inflated as shown in FIG. 7. Inflation is achieved byconnecting the syringe 48 to the valve assembly 50, and depressing theplunger (not shown) of the syringe 48 to force fluid through theinflation passageway 42 of the inflation tube 44, into the inflationconduit 76, through the opening 72 and into the interior volume 74,causing the flexible sleeve 66 to expand into the balloon 40. After theballoon 40 is in the expanded position, the insertion tool 22 is pulledto move the catheter-tool assembly 24 in the proximal direction untilthe inflated balloon 40 seats against the bladder neck 46.

With the balloon 40 seated against the bladder neck 46, continuedproximal movement of the insertion tool 22 causes the separableconnection 52 to separate the indwelling catheter 20 from the insertiontool 22, as shown in FIG. 8. The balloon 40 prevents the indwellingcatheter 20 from coming out of the urinary tract 26 with the insertiontool 22 because the expanded balloon 40 is larger than the bladder neck46. The coiled section 54 of the inflation tube 44, being locatedproximally from the external urinary sphincter muscle 34, prevents theindwelling catheter 20 from moving into the bladder 32. The continuedwithdrawal of the insertion tool 22 is not inhibited by the coiledsection 54, because the body of the insertion tool 22 moves through theinterior of the coiled section 54. The length of the inflation tube 44is sufficient to locate the valve assembly 50 at the exterior of theurinary tract 26.

After the insertion tool 22 is removed as shown in FIG. 9, the balloon40 remains inflated in the bladder 32, and the proximal end of the mainbody 58 of the indwelling catheter 20 extends through the prostaticurethra 28 but does not extend through the external urinary sphinctermuscle 34. The coiled section 54 is located on the opposite or proximalside of the external urinary sphincter muscle 34. In this finalposition, the balloon 40 prevents the indwelling catheter 20 from movingout of the prostatic urethra 28 and into the urinary canal 36, while thecoiled section 54 prevents the indwelling catheter 20 from moving out ofthe prostatic urethra 28 and into the bladder 32. The inflation tube 44does not interfere with the ability of the urinary sphincter muscle 34to constrict around the inflation tube 44 and naturally stop the urineflow. Similarly, the inflation tube 44 does not interfere with thenatural ability of the external urinary sphincter muscle 34 to dilate,as shown in FIG. 9, and thereby naturally allow urine to flow throughthe interior passageway 56 of the indwelling catheter 20 and into theurinary canal 36. In this manner, the inflation tube 44 does notinterfere with the natural control functions of the external urinarysphincter muscle 34.

When the urinary sphincter muscle 34 is dilated, the urine flows fromthe bladder 32 through the openings 64 and into the interior passageway56 in the main body 58, as understood from FIG. 3. The flow of urinethrough the interior passageway 56 largely bypasses the prostaticurethra 28 or the prostate gland tissue if the prostatic urethra 28 hasbeen removed by a surgical procedure. The dilated urinary sphinctermuscle 34 (FIG. 9) allows urine to flow from the interior passageway 56of the indwelling catheter 20 through the urinary canal 36 in the normalmanner. Constriction of the urinary sphincter muscle 34 around theinflation tube 44 stops the urine flow.

While the urinary sphincter muscle 34 is dilated to permit urine flow,the balloon 40 prevents the indwelling catheter 20 from exiting thebladder 32 and moving into the dilated urinary sphincter muscle 34. Thecontact of the coiled section 54 against the urethra of the urinarycanal 36 resists movement of the indwelling catheter 20 into and out ofthe bladder 32. In addition, the inflation tube 44 can be held at thevalve assembly 50 to resist distal movement of the indwelling catheter20 during urination when the urinary sphincter muscle 34 is dilated, ifnecessary or desirable. In this manner, the indwelling catheter 20 staysin position even when the urinary sphincter muscle 34 is dilated.

When the indwelling catheter 20 is no longer needed, typically as aresult of natural healing of the prostate gland 30 after a surgical orheat treatment procedure, or if it is necessary to periodically replacethe indwelling catheter 20, removal is accomplished after deflating theballoon 40. Deflation is accomplished by inserting the syringe 48 intothe valve assembly 50 and moving the plunger (not shown) of the syringe48 outward to withdraw fluid from the inflation passageway 42. Theinsertion of the syringe 48 in the valve assembly 50 opens the checkvalve within the valve assembly 50 and allows the fluid to be withdrawn.If the inflation tube 44 has been tied into a knot or an obstruction hasbeen formed to avoid use of the valve assembly 50 in the mannerdescribed above, the inflation tube 44 may be cut at a location distalof the knot or obstruction to allow the fluid to escape. The escapingfluid causes the balloon 40 to deflate, and the flexible sleeve 66 movesto a collapsed position (shown in FIGS. 1 and 6) adjacent to the mainbody 58 of the indwelling catheter 20.

Once the balloon 40 has been deflated, the inflation tube 44 is pulledoutward by gripping and pulling on the valve assembly 50 or the proximalend of the inflation tube 44. Force is transferred through the inflationtube 44 to the main body 58 of the indwelling catheter 20. The pullingforce constricts and elongates the coils of the coiled section 54,thereby reducing their transverse dimension as a result oflongitudinally separating the individual coils with the pulling force.The reduced transverse dimension lessens or eliminates contact with theurinary canal 36. In this manner the coiled section does not inhibitremoval of the catheter or induce significant discomfort as it movesthrough the urinary canal. The amount of force transferred is sufficientto move the main body 58 of the indwelling catheter 20 past the urinarysphincter muscle 34 and into the urinary canal 36. The deflated balloon40 does not resist movement of the distal end of the indwelling catheter20 through the bladder neck 46. Continued pulling movement on theinflation tube 44 moves the indwelling catheter 20 through the urinarycanal 36 until the indwelling catheter 20 is completely withdrawn fromthe proximal end of the urinary canal 36.

In many TUMT and heat treatment procedures, blood from the affectedtissue tends to accumulate in the bladder. The blood flows out of thebladder during natural urination. With the indwelling catheter 20located in the use position described above, blood could clot within theinterior passageway 56 of the indwelling catheter 20 or blood clots mayaccumulate to the degree that the interior passageway 56 or openings 64are blocked or obstructed. Natural pressure from the bladder may beinsufficient to overcome the blockage, thereby preventing urine flowfrom the bladder 32 through the catheter 20. Under such circumstances,it is necessary to remove the obstructed catheter and insert a newcatheter, in the manner described above. Replacing an obstructedcatheter is to be avoided if possible, because the removal and insertionfurther aggravates the already-tender tissue within the prostate glandthat has been affected by the surgical procedure.

One approach which avoids replacing the catheter under circumstanceswhere blood clots accumulate in the interior passageway 56 is to flushthe interior passageway 56 with saline or other appropriate liquid on aperiodic basis. To do so, it is necessary to establish fluidcommunication through the urinary canal 36, the constricted externalurinary sphincter muscle 34 and into the interior passageway 56 of thecatheter 20. The most direct manner of establishing this type of fluidcommunication is to maintain the insertion tool 22 connected to theindwelling catheter 20, so that the flushing fluid can be suppliedthrough an interior channel 88 of the insertion tool 22 from the handle82, as understood from FIG. 10. The flushing fluid passes through theinterior channel 88 and through the center opening 86 of the sleeve 84and into the passageway 56 of the indwelling catheter 20. The flushingfluid forces any blood clots which accumulated in the interiorpassageway 56 back into the bladder 32 (FIG. 6) or dissolves the clotswithin the interior passageway 56. Removing the clots relieves theobstruction and allows urine to flow through the indwelling catheter inthe manner described.

Until the affected tissue stops bleeding, there is a risk that the clotswill continue to form within the passageway 56. The risks of obstructionfrom blood clots is normally the greatest within the first twenty-fourhours after a TUMT or heat treatment procedure. During this time period,it is desirable to provide the ability to flush the interior passageway56. To provide the ability to flush the interior passageway, theinsertion tool 22 must remain connected to the indwelling catheter 20during this time so that the interior channel 88 of the insertion tool22 remains in fluid communication with the interior passageway 56,through the center opening 86 of the sleeve 84.

Instead of pulling the insertion tool 22 in the proximal direction toseparate the insertion tool 22 from the indwelling catheter 20 at theseparable connection 52 after the indwelling catheter has been locatedin the use position (FIG. 8), the insertion tool 22 may be left in placefor approximately the first twenty-four hours. The natural frictionbetween the proximal end of the main body 58 of the indwelling catheter20 and the distal portion of the sleeve 84 connected to the insertiontool 22 may be sufficient to maintain the insertion tool 22 connected tothe indwelling catheter in some circumstances. However in othercircumstances, the patient may be released from the supervision ofmedical personnel immediately after the procedure and will be ambulatoryduring the first twenty-four hour period after the procedure. Movementof the patient under these circumstances may tend to create enough forceon the insertion tool 22 to disconnect the insertion tool from theindwelling catheter prematurely before the risk of blood clots hassubsided.

To assure that the insertion tool 22 remains connected to the indwellingcatheter 20 at the separable connection 52 until medical personneldetermines that it is appropriate to separate the indwelling catheter 20from the insertion tool 22, a bridging structure, preferably in the formof a relatively fine thread-like cord 90, is used to maintaintemporarily the separable connection 52 of the indwelling catheter 20and the insertion tool 22, as shown in FIG. 10. The cord 90 extends fromthe interior passageway 56 through a small hole 92 in the sidewall 60 ofthe main body 58 of the indwelling catheter 20. From the hole 92, thecord 90 extends across and bridges the separable connection 52 along anoutside surface of the main body 58 of the indwelling catheter and alongan outside surface of a tubular main body 98 of the insertion tool 22.The cord also extends through another small hole 94 in a sidewall 96 ofa main tubular body 98 of the insertion tool 22, and into the interiorchannel 88. The two opposite free-end portions of the cord 90 extendalong the length of the interior channel 88 and terminate within thehollow interior of the handle 82. The terminal end portions of the cord90 each loop through small holes 100 and 102 formed in a sidewall 104 ofa main body 106 of the handle 82. Knots 108 are formed in the terminalend portions of the cord 90 within the hollow interior of the handle 82to hold each end of the cord 90 in place relative to the handle 82.

Any slack longitudinal length of the cord 90 is eliminated when theknots 108 are tied in the terminal ends of the cord 90. Eliminating anylongitudinal slack in the cord 90 pulls together the proximal end of theindwelling catheter 20 and the distal end of the insertion tool 22. Thecord 90 therefore prevents the indwelling catheter 20 from separatingfrom the insertion tool 22 at the separable connection 52. Thecommunication channel through the interior channel 88, the centeropening 86 of the sleeve 84 and the interior passageway 56 is maintainedso long as the cord 90 connects the indwelling catheter 20 and theinsertion tool 22.

While the indwelling catheter 20 is maintained connected to theinsertion tool 22, flushing fluid may be forced from the handle 82through the interior channel 88, through the center opening 86 and intothe interior passageway 56. The flushing fluid dissolves any clotswithin the interior passageway 56, and keeps the passageway 56unobstructed for urine flow from the bladder. The dissolved clots mayflow from the interior passageway 56 through the interior channel 88, orthe clots may be pushed back into the bladder with the flushing fluid.Of course, while the open communication path exists through theinsertion tool 22 and the indwelling catheter 20, urine from the bladderwill also flow through this open path. To control the urine flow underthese circumstances, it is necessary to insert a valve in the interiorchannel 88 at the handle 82, to control the discharge of the urine. Theextension of the insertion tool 22 through the sphincter muscle 34prevents the sphincter muscle from naturally controlling the urine flow.

When it is determined that the risk of blood clots has diminished and itis no longer necessary or desirable to flush the interior passageway 56of the indwelling catheter 20, preferably at least twenty-four hoursafter the procedure, one or both of the knots 108 is untied or cut. Oneend of the cord 90 is pulled in the proximal direction, which moves theother free end of the cord into the interior channel 88, through theholes 92 and 94 and then out of the interior channel 88, therebydisconnecting the indwelling catheter 20 from the insertion tool 22 atthe separable connection 50. Once the cord 90 no longer holds theindwelling catheter and the insertion tool together as shown in FIG. 10,the insertion tool 22 is pulled in the proximal direction to separate itfrom the indwelling catheter 20 in the manner previously described andshown in FIG. 8. The indwelling catheter 20 remains in the use positionshown in FIG. 9.

The resistance to clotting, both before and after the insertion tool 22is removed from the indwelling catheter 20, is enhanced by coating theindwelling catheter 20 and portions of the insertion tool 22 with alayer or coating 109 of low friction material, such as parylene or ahydrophilic material, as shown in FIG. 3. The coating 109 of the lowfriction material is applied to the main body 58, to cover its sidewall60 on the exterior and interior, including the passageway 56, the endpiece 62 and the openings 64 within the end piece 62. In othercircumstances, an outer layer 109 of the low friction material may beintegrally made a part of the sidewall 60, including the passageway 56and the openings 64. The low friction material reduces the adherence ofthe blood clots within the openings 64 and in the passageway 56, andreduces the frictional force holding those blood clots in the openings64 and the passageway 56. The reduced adherence or frictional holdingforce makes it easier to dislodge the clots, with natural fluid pressurefrom the bladder or when flushing the indwelling catheter with fluidthrough the insertion tool in the manner previously described, or inconjunction with the action of a clearing device described below. Thelow friction material on the interior surface of the passageway 56 alsoreduces the resistance to the flow of urine and clots or other potentialobstruction through the passageway 56. The low friction material on theexterior surface of the main body 58 and on the exterior surface of theinsertion tool 22 facilitates insertion of the indwelling catheter inthe urinary canal 36.

Another technique for obtaining increased resistance to blood clotobstructions of the interior passageway 56 within the catheter 20 is toincrease the size of the inlet opening or openings 64 through the endpiece 62, or to orient the inlet opening 64 in a manner which inhibitsclot accumulation, or to do both. Preferably, the cross-sectional sizeof the inlet opening or the cumulative cross-sectional sizes of all ofthe inlet openings should be substantially greater than thecross-sectional size of the interior passageway 56, preferably at leasttwo to four or more times greater. Indwelling catheters 20 a-20 d whichemploy inlet openings 64 of increased size and direct orientation areshown in FIGS. 11-14. The layer or coating 109 (FIG. 3) of the lowfriction material may also be used in conjunction with the catheters 20a-20 d shown in FIGS. 11-14.

The catheter 20 a shown in FIG. 11 has a single enlarged urine drainageinlet opening 64 a formed in the end piece 62 a. The end piece 62 aretains the longitudinal half structure or portion of the rounded distalend 38 of the end piece 62 (FIGS. 2 and 3), but the other longitudinalhalf portion is eliminated for a substantial longitudinal distanceextending proximally from the most distal point of the rounded end 38 tocreate the substantially enlarged inlet opening 64 a. The shape of theend piece 62 a and the inlet opening 64 a cause the distal end of theindwelling catheter 20 a to assume the shape or configuration of awhistle. For that reason, the catheter 20 a is referred to as having awhistle tip 110. The substantially enlarged inlet opening 64 a into theinterior passageway 56 (FIG. 3) from the bladder 32 makes it difficultfor blood clots to accumulate within the inlet opening 64 a and toobstruct urine flow into and through the passageway 56. The roundeddistal end portion of the whistle tip 110 facilitates the insertion ofthe catheter 20 a into the urinary canal 36.

The indwelling catheter 20 b shown in FIG. 12 has multiple urinedrainage inlet openings 64 b spaced at longitudinal and circumferentialpositions around the end piece 62 b. Each of the inlet openings 64 bcommunicates from the exterior of the end piece 62 b into the interiorpassageway 56. Each of the inlet openings 64 b is approximately the samesize as, or slightly smaller than, each of the pair of inlet openings 64in the rounded distal end 38 of the end piece 62 (FIGS. 2 and 3), butthe multiplicity of the inlet opening 64 b provides a cumulativelylarger pathway for the urine to pass from the bladder into thepassageway 56 of the catheter 20 b. Having a multiplicity of inletopenings 64 b rather than a single inlet opening 64 or a pair of inletopenings 64 decreases the possibility that a blood clot will preventurine from flowing into the interior passageway 56 (FIG. 3) from thebladder 32, and decreases the possibility of a single clot entering thecatheter 20 b and blocking the passageway 56 (FIG. 3). In the event thatone or more of the inlet openings 64 b becomes obstructed with a bloodclot, urine will flow into the passageway 56 through one or more of theother unobstructed openings 64 b. The multiple urine drainage inletopenings 64 b in the catheter 20 b cause it to be referred to as havinga multiple opening tip 111. The rounded distal end 38 of the multipleopening tip 111 facilitates the insertion of the catheter 20 b into theurinary canal 36.

The indwelling catheter 20 c shown in FIG. 13 has a couvelaire tip 112.The couvelaire tip 112 has a pair of relatively-large elongated oroval-shaped inlet openings 64 c positioned on diametrically oppositesides of the end piece 62 c. The enlarged inlet openings 64 c aresignificantly larger than the inlet openings 62 typically found in acatheter (FIGS. 2 and 3). Preferably, the cross-sectional size of eachof the inlet openings 64 c is significantly greater than thecross-sectional size of the interior passageway 56. In addition, atransverse dimension of each inlet opening 64 c is preferably greaterthan one fourth of the circumferential distance around the main body 58and the longitudinal dimension of each inlet opening 64 c is greaterthan the transverse dimension. The enlarged size makes it difficult forblood clots to accumulate within the inlet openings 64 c and to obstructurine flow into and through the interior passageway 56 (FIG. 3). Therounded distal end 38 of the couvelaire tip 112 facilitates theinsertion of the catheter 20 c into the urinary canal 36.

The indwelling catheter 20 d shown in FIG. 14 has a beveled tip 114. Theend piece 62 d includes a somewhat flat beveled surface 116 that extendsat an acute angle more transversely relative to the axis of the catheterfrom the distal end 38 of the end piece 62 d than longitudinally. Asingle urine drainage inlet opening 64 d is formed through the beveledsurface 116. Because of the transverse angle of the beveled surface 116relative to the axis of the catheter 20, the flow passageway through theinlet opening 64 d more directly aligns with and enters the interiorpassageway 56 (FIG. 3). The single inlet opening 64 d can be made of asize larger than the cross-sectional size of the passageway 56. Themore-directly entering flow passageway through the inlet opening 64 davoids the right angle turn associated with the openings 62 in the endpiece 64 (FIGS. 2 and 3). The more-directly entering flow passagewaythrough the inlet opening 64 d provides less of an obstruction orrestriction for the blood clots to accumulate and to obstruct thepassageway 56. The end piece 62 d retains a rounded distal end 38 whichfacilitates insertion of the catheter 20 d into urinary canal 36. Thebeveled surface 116 also facilitates insertion of the catheter 20 d intothe urinary canal.

Obstructions from blood clots and other urinary tract matter can also beavoided by incorporating a clearing device 120 within the indwellingcatheter 20 e, as shown in FIG. 15. The clearing device 120 is locatedwithin the interior passageway 56 of the catheter 20 e and includes anobstruction clearing contact element (e.g., brush structure 122) whichis movable longitudinally along the interior passageway 56. Theobstruction clearing contact element dislodges the blood clots or otherobstructions within the passageway 56, or breaks the blood clots orobstructions into smaller pieces, or breaks open the accumulation ofclots or obstructions in the openings 64, as a result of movement of theclot clearing contact element within the passageway 56, as shown in FIG.16. Dislodging or breaking up the clots and obstructions opens thepassageway 56 to the flow of urine and carries the obstructions out ofthe urinary tract with the flow of urine.

One form of the contact element of the clearing device 120 utilizes abrush structure 122 formed by a plurality of bristles held together toform the brush structure 122. Under normal use conditions, the brushstructure 122 is retained in a stowed position at an internal distal end124 of the passageway 56 within the end piece 62, spaced slightlydistally from the inlet openings 64, as shown in FIG. 15. The brushstructure 122 is held in the stowed position by bias force from a returnspring 126 which extends between the brush structure 122 and theinternal distal end 124 of the passageway 56. In its stowed position,the brush structure 122 does not interfere with the flow of urinethrough the inlet openings 64 and the interior passageway 56.

A thread-like tether 128 is attached to the brush structure 122 and thespring 126, and the tether 128 extends through the passageway 56 of thecatheter 20 e on the opposite side of the brush structure 122 from thereturn spring 126. When the catheter 20 e is attached to the insertiontool 22 (FIG. 1), the tether 128 extends through the passageway 56 andthe interior channel 88 of the insertion tool 22 (FIG. 10) and out ofthe handle 82 (FIG. 1). Once the indwelling catheter 20 e has beeninserted into the urinary canal 36 in its final position within thebladder and the prostatic urethra (FIG. 7), the insertion tool 22 isdisconnected from the indwelling catheter 20 e and the insertion tool 22is removed in the manner previously described. The tether 128 remains inposition within the urinary canal 36 as the insertion tool 22 isremoved, as a result of the tether 128 moving through the interiorchannel 88 of the insertion tool. The proximal end of the tether 128remains exterior of the urinary canal 36.

When it is determined that the urine flow path through the passageway 56is obstructed by blood clots, the brush structure 122 is moved out ofthe stowed position (FIG. 15) and is moved longitudinally proximallyalong the interior passageway 56 by pulling proximal end of the tether128 at the exterior of the urinary canal 36, as shown in FIG. 16. Theresiliency of the return spring 126 permits proximal longitudinalmovement. As the brush structure 122 moves along the passageway 56, theblood clots or obstructions are contacted by the brush structure 122.The longitudinal movement of the brush structure dislodges and shearsthe clots out of the inlet openings 64 and the passageway 56. Deflectedbristles of the brush structure 122 within the interior passageway 56spring outwardly through the inlet openings 64 to push the clots orobstructions out of those inlet openings. The bristles of the brushstructure 122 also shear or break the clots or obstructions within theinlet openings and the passageway 56 into smaller pieces. The dislodged,broken and smaller clots or obstructions flow with the urine through theopened passageway 56 and into the urinary canal 36, or the movement ofthe brush structure 122 pushes the clots or obstructions through thepassageway 56 out of the catheter 20 e. The clots or obstructionsthereafter pass through the remaining portion of the urinary canal 36and out of the body by the flow of urine. The tether 128 constitutes oneform of an activation device for operating the obstruction clearingdevice 120.

After the brush structure 122 has cleared the clots from the inletopening 64 and the passageway 56, the tether 128 is released and thereturn spring 126 pulls the brush structure 122 from the position shownin FIG. 16 back into the stowed position at the internal distal end 124of the passageway 56 shown in FIG. 15. Thereafter, urine may again flowthrough the passageway 56 in the normal matter. Should the inlet opening64 or the passageway 56 again become obstructed, the brush structure 122can again be moved longitudinally by pulling on the tether 128 to againclear the urine flow path through the inlet openings 64 and thepassageway 56. The clearing device 120 can be used as many times asneeded in this manner to keep the catheter 20 e open to the flow ofurine.

An alternative form of the clearing device 120 provides for a one-timeuse to clear the urine flow passageway. In this circumstance, the returnspring 126 is omitted. The brush structure 122 is retained in the stowedposition (FIG. 15) by frictional forces between the bristles and theinside surface of the passageway 56 at the internal distal end 124. Ifthe urine flow through the passageway 56 becomes obstructed, the tether128 is pulled and the brush structure 122 is moved from the stowedposition longitudinally through the passageway 56 (FIG. 16), therebyclearing the passageway of clots or obstructions. Continuing to pull thetether 128 removes the brush structure 122 from the interior passageway56 and into the urinary canal 36. The clearing device 120 is then pulledcompletely out of the urinary canal 36.

In this way the obstruction is removed at the same time that the brushstructure 122 is removed from within the indwelling catheter 20 e. Whilethe clearing device 120 can only be used once in this manner, a singleuse may prove satisfactory for those TUMT, heat treatment and otherpatients for whom blood clots and other obstructions are not expected tobe a significant issue. Also, the use of the single-use clearingindwelling catheter 20 e may be prescribed if the physician knows orprefers to replace the indwelling catheter 20 e on a periodic basisduring healing.

The clearing device 120 can be used while the insertion tool 22 remainsconnected to the indwelling catheter 20 e for flushing the catheter 20.The tether 128 extends through the interior channel 88 in the insertiontool 22 and therefore does not interfere with the flow of flushing fluidthrough the interior channel 88 and into the interior passageway 56.Clearing the blood clots or obstructions by use of the clearing device120 in combination with flushing or in alternation with flushing, may bereserved for those situations where flushing by itself is insufficientto eliminate the obstructions. Using the clearing device 120 can alsoenhance the effect of the flushing, by loosening and breaking the clotsor obstructions prior to flushing. In this manner, the amount and extentof flushing may be reduced, which can be important in minimizing thediscomfort associated with forcing additional flushing fluid into analready-filled bladder.

Forcing the flushing fluid into the interior channel 88 and interiorpassageway 56 may also move the brush structure 122 back to the stowedposition. In this circumstance, the return spring 126 is not needed toobtain multiple uses of the clearing device 120. Forcing the flushingfluid into the interior channel 88 and interior passageway 56 may alsohelp to move the brush structure 122 back to the stowed position,thereby assisting the return spring 126.

In those catheters having inlet openings 64 spaced slightly proximallyof the distal most end 38 (e.g. FIGS. 3, 12, 13), as represented in FIG.15, the stowed position of the clearing device 120 is slightly distal ofthe most distal openings 64 within the interior passageway 56. In thosecatheters which have inlet openings that extend to or through the distalmost end 38 (e.g. FIGS. 11 and 14), the clearing device 120 may take adifferent form from the brush structure 122 or a part of the urine flowmay normally pass through the brush structure 122. The different form ofthe clearing device 120 may permit it to move out of the path of thenormal urine flow through the interior passageway 56 yet move across theinlet openings 64 and along the interior passageway 56 in such a way toclear obstructions within the inlet openings. This may be accomplishedby rotating and longitudinally moving the clearing device 120 within theinterior passageway 56, rather than solely moving the clearing device120 longitudinally within the interior passageway 56. If the inletopenings 64 are sufficiently large, the exposed brush structure 122 maynot substantially interfere with normal urine flow, because the size ofthe inlet opening 64 is so large that the presence of the brushstructure 122 at a portion of the inlet openings 64 is not significant.Any clots which might form on the brush structure 120 to itself arebroken as the brush structure moves into the interior passageway 56,while still breaking, sharing and dislodging other obstructions presentin the interior passageway.

Although the enlarged urinary inlet opening configurations of 64 a-64 dand the clearing device 120 have been shown in connection with apartial-length indwelling catheter, they are also applicable for use infull-length catheters. Use with a full-length catheter occurs in thesame manner as occurs while the insertion tool 22 remains connected tothe partial length catheter.

In the manner described, the partial-length catheter allows voluntarynatural use of the external urinary sphincter muscle 34 to start andstop urine flow. The location of the indwelling catheter within theprostate gland 30 bypasses most of the urine flow from contact with thetissue of the prostate gland 30 which has been affected by the surgicalprocedure, thereby preventing or lessening pain and irritation. Anyblood which may accumulate within the interior passageway of theindwelling catheter, and possibly cause obstructions due to clots, isflushed and cleared from the interior of the indwelling catheter priorto removal of the insertion tool 22. The separation of the insertiontool 22 from the indwelling catheter 20 may be delayed until the risksof obstructions from blood clots and the like has passed.

The indwelling catheter also assures a passageway for urine to flowthrough a prostate gland 30 that is diseased and swollen from BPH orother diseases. The catheter reliably remains in position for use due tothe anchoring effects of the inflated balloon 40 and the coiled section54, thereby lessening the risk of further surgical procedures toreposition and remove an inadvertently displaced catheter. Obstructionsblocking the urine flow into and through the catheter, such as bloodclots, are reduced or eliminated by the low friction coating and thevarious configurations of the inlet openings 64 at the distal end of thecatheter. If the interior passageway 56 does become obstructed, theblood clot or other obstruction clearing device 120 is selectivelymovable within the passageway 56 to eliminate the obstruction withouthaving to resort to a surgical procedure for replacing the catheter 20.

Presently preferred embodiments of the invention and many of itsimprovements have been described above with a degree of particularity.The description is of preferred examples for implementing the invention,and is not necessarily intended to limit the scope of the invention. Thescope of the invention is defined by the following claims.

1. A catheter for insertion in a urinary tract to drain urine from abladder to a location adjacent to an orifice in an external urinarysphincter muscle which controls urine flow into a urinary canal of theurinary tract, comprising: a main body having a distal end, a proximalend and a length sufficient to position the distal end within thebladder and to position the proximal end adjacent to and distal of theorifice in the external urinary sphincter muscle, the main body definingan urine drainage interior passageway extending from the distal end tothe proximal end, the interior passageway having a cross-sectional size;a distal anchor attached to the distal end of the main body andexpandable within the bladder to restrain the main body against proximalmovement within the urinary tract from a use position in which thedistal end of the main body is located in the bladder and the proximalend of the main body is located adjacent to and distal of the orifice inthe external urinary sphincter muscle; a proximal anchor attached to theproximal end of the main body to restrain the main body against distalmovement in the urinary tract from the use position; and at least oneurine inlet opening extending through the distal end of the main bodyand into the interior passageway, each inlet opening having a crosssectional size, the cumulative cross-sectional size of all inletopenings in the distal end being greater than the cross-sectional sizeof the interior passageway to facilitate passing urine and blood clotsfrom the bladder into the interior passageway while reducing anaccumulation of blood clots within the inlet opening and the interiorpassageway.
 2. A catheter as defined in claim 1, wherein: the distal endincludes a rounded tip; a single inlet opening extends through thedistal end of the main body; the single inlet opening has apredetermined configuration; and the predetermined configuration of theinlet opening is defined by the absence of a longitudinal half portionof the rounded tip and the distal end adjacent to the rounded tip, thelongitudinal half portion defined substantially by a longitudinalbisection of the rounded tip and the portion of the distal end adjoiningthe rounded tip.
 3. A catheter as defined in claim 2, wherein: thesingle inlet opening and a remaining longitudinal half portion of therounded tip and the distal end establish a whistle-tip shape of thedistal end of the main body.
 4. A catheter as defined in claim 1,wherein: the distal end includes a rounded tip; a plurality of inletopenings extend through the distal end of the main body; and each of theinlet openings is longitudinally spaced from an adjacent inlet openingalong the portion of the distal end adjacent to the rounded tip.
 5. Acatheter as defined in claim 4, wherein: each of the inlet openings isalso circumferentially spaced from an adjacent inlet opening along theportion of the distal end adjacent to the rounded tip.
 6. A catheter asdefined in claim 1, wherein: the distal end includes a rounded tip; twoinlet openings extend through the distal end of the main body; and thetwo inlet openings are positioned radially opposite one another on thedistal portion of the main body adjacent to the rounded tip, each of thetwo inlet openings has a cross-sectional size, and the cross-sectionalsize of each of the two inlet openings is substantially greater than thecross-sectional size of the interior passageway.
 7. A catheter asdefined in claim 6, wherein: each of the two inlet openings has acircumferential dimension greater than one-fourth of the circumferentialdistance around the main body.
 8. A catheter as defined in claim 6,wherein: each of the two inlet openings is elongated with a longerdimension of each elongated opening extending longitudinally along thedistal end.
 9. A catheter as defined in claim 6, wherein: each of thetwo inlet openings defines a couvelaire tip configuration of the distalend of the main body.
 10. A catheter as defined in claim 1, wherein: thedistal end includes a beveled surface which extends substantiallytransversely at an acute angle relative to a longitudinal axis throughthe distal end; a single inlet opening extends through the distal end ofthe main body; and the single inlet opening extends through the beveledsurface substantially directly into the interior passageway of the mainbody.
 11. A catheter as defined in claim 1, further comprising: a lowfriction coating extending over the distal end, within each inletopening, and along the interior passageway.
 12. A catheter as defined inclaim 1, further comprising: a clearing device positioned within theinterior passageway and including a contact element movable within theinterior passageway past each inlet opening to contact and disintegrateand facilitate movement of blood clots and obstructions within eachinlet opening and the interior passageway with the flow of urine throughthe interior passageway.
 13. A catheter as defined in claim 12, wherein:the contact element is normally positioned within the interiorpassageway in a stowed position between each inlet opening and a distalend of the interior passageway; and the contact element is movable fromthe stowed position to a position proximal of each inlet opening in theinterior passageway through the main body.
 14. A catheter as defined inclaim 13, further comprising: an activation device connected to thecontact element and extending through the urinary canal to a positionoutside an exterior opening of the urinary canal; and wherein: thecontact element is selectively moved by manipulation of the activationdevice at the position outside the exterior opening of the urinarycanal.
 15. A catheter as defined in claim 14, further comprising incombination: an insertion tool for inserting the catheter into theurinary tract to the use position, the insertion tool having a distalend for connecting with the proximal end of the main body and a proximalend that extends to a position outside the exterior opening of theurinary canal, the insertion tool having an interior channel extendingfrom its distal end to its proximal end, the interior channelcommunicating with the interior passageway in the main body when thedistal end of the insertion tool is connected to the proximal end of themain body; and wherein: the activation device extends through theinterior channel of the insertion tool when the insertion tool isconnected to the main body.
 16. A catheter as defined in claim 1,wherein: the distal anchor comprises a balloon attached to the distalend of the main body, the balloon is expandable in size when inflatedwithin the bladder to maintain the distal end of the main body in thebladder and to restrain the main body against proximal movement from theuse position; and further comprising: an inflation tube having a distalend, a proximal end and a length extending between the distal andproximal ends, the distal end of the inflation tube connected to themain body, the length of the inflation tube sufficient to extend fromthe main body through the orifice of the external urinary sphinctermuscle and the urinary canal to a position outside of an exterioropening of the urinary canal, the inflation tube and the main bodyestablishing an inflation passageway extending from the proximal end ofthe inflation tube to the balloon through which to deliver fluid toinflate the balloon.
 17. A catheter as defined in claim 16, wherein: theproximal anchor comprises a coiled section of the inflation tube locatedat a position adjacent to and proximal of the sphincter muscle when themain body is in the use position, the coiled section interacting withthe external urinary sphincter muscle when constricted to restrain themain body against distal movement from the use position
 18. A method ofmaking an urinary catheter more resistant to obstructions from bloodclots in a urine flowpath from a bladder through an interior passagewayof the catheter, comprising: locating at least one urine inlet openingwithin an end piece of the catheter to conduct urine from the bladderinto the interior passageway when the end piece is located in thebladder; and forming each inlet opening with a predeterminedconfiguration and a cross-sectional size to facilitate passing urine andblood clots from the bladder into the interior passageway while reducingan accumulation of blood clots within the inlet opening and the interiorpassageway, the cumulative cross-sectional size of all inlet openingsbeing greater than the cross-sectional size of the interior passageway.19. A method as defined in claim 18, further comprising: forming asingle inlet opening in a configuration of a whistle tip.
 20. A methodas defined in claim 18, further comprising: forming a single inletopening in a configuration in which a substantially longitudinallybisectioned portion of the end piece is absent.
 21. A method as definedin claim 18, further comprising: forming a plurality of separate inletopenings each of which is longitudinally spaced from an adjacentseparate opening along the end piece.
 22. A method as defined in claim18, further comprising: forming a plurality of separate inlet openingseach of which is circumferentially spaced from an adjacent separateopening around the end piece.
 23. A method as defined in claim 18,further comprising: forming a plurality of separate openings each ofwhich is longitudinally and circumferentially spaced from an adjoiningseparate opening on the end piece.
 24. A method as defined in claim 18,further comprising: forming two separate openings at radially oppositepositions on the end piece as a couvelaire tip.
 25. A method as definedin claim 18, further comprising: forming two separate openings atradially opposite positions on the end piece; and forming each of thetwo separate openings with a greater longitudinal dimension than acircumferential dimension.
 26. A method as defined in claim 18, furthercomprising: creating a beveled portion on the end piece which extends ata more transverse rather than longitudinal angle relative to alongitudinal axis through the end piece; forming a single inlet openingthrough the end piece; and extending the single inlet opening throughthe beveled surface substantially directly into the interior passagewayof the main body.
 27. A method as defined in claim 18, furthercomprising: coating the end piece, each inlet opening and the interiorpassageway with a low friction coating.
 28. A method as defined in claim18, further comprising: positioning a contact element within theinterior passageway for movement within the interior passageway andrelative to each inlet opening and the interior passageway; and movingthe contact element within the interior passageway to contact anddisintegrate and facilitate movement of blood clots and obstructionswithin at least one inlet opening and the interior passageway with theflow of urine through the interior passageway.
 29. A catheter forinsertion in an urinary tract to drain urine from a bladder through aurinary canal and out of an exterior opening of the urinary canal,comprising: a main body having a distal end and a length sufficient toposition the distal end within the bladder, the main body defining anurine drainage interior passageway; an urine inlet opening extendingthrough the distal end into the interior passageway to pass urine fromthe bladder into the interior passageway; and a clearing devicecomprising a contact element moveably positioned within the interiorpassageway for movement past the inlet opening and along the interiorpassageway to contact and disintegrate and facilitate movement of bloodclots and obstructions within the inlet opening and the interiorpassageway with the flow of urine through the interior passageway.
 30. Acatheter as defined in claim 29, further comprising: an activationdevice connected to the contact element and extending through theinterior passageway and extendable from the main body through theurinary canal to a position outside of the exterior opening of theurinary canal, the activation device moving the contact element bymanipulation of the activation device at the position outside theexterior opening of the urinary canal.
 31. A catheter as defined inclaim 30, wherein: the activation device comprises a tether connected tothe contact element to move the contact element past the inlet openingand along the interior passageway upon pulling the tether at theposition outside the exterior opening of the urinary canal.
 32. Acatheter as defined in claim 31, wherein: the contact element isretained within the interior passageway for removal and transportationthrough the interior passageway and out of the main body by pulling thetether after moving the contact element past the inlet opening.
 33. Acatheter as defined in claim 30, further comprising: a return elementconnected between the contact element and the main body to bias thecontact element into an initial position from which the contact elementcommences movement; and the return element moving the contact elementback to approximately the initial position after the contact element hasbeen moved past the inlet opening and along the interior passageway. 34.A catheter as defined in claim 33, wherein: the return element comprisesa spring.
 35. A catheter as defined in claim 33, wherein: the activationdevice comprises a tether connected to the contact element to move thecontact element past the inlet opening and along the interior passagewayupon pulling the tether at the position outside the exterior opening ofthe urinary canal.
 36. A catheter as defined in claim 30, wherein: thecontact element is positioned within the interior passageway for removalout of the main body after the contact element has been moved past theinlet opening and along the interior passageway.
 37. A catheter asdefined in claim 36, wherein: the activation device comprises a tetherconnected to the contact element to move the contact element past theinlet opening and along the interior passageway and remove the contactelement out of the main body upon pulling the tether at the positionoutside the exterior opening of the urinary tract.
 38. A catheter asdefined in claim 29, wherein: the contact element comprises a brushstructure.
 39. A catheter as defined in claim 38, wherein: the brushstructure includes a plurality of bristles.
 40. A catheter as defined inclaim 39, wherein: the brush structure is maintained in the interiorpassageway by friction between the bristles and the interior passagewayuntil the contact member is moved.
 41. A catheter as defined in claim29, wherein: the contact element occupies an initial position within theinterior passageway from which the contact element commences movement;and the contact member is returned to the starting position by theapplication of fluid pressure through the interior passageway of themain body after the contact element has been moved past the inletopening and along the interior passageway.
 42. A catheter as defined inclaim 29 wherein the catheter is of the partial-length indwelling typeused to drain urine from the bladder to a location adjacent to anorifice in an external urinary sphincter muscle which controls urineflow into a urinary canal of the urinary tract, wherein: the main bodyhas a distal end, a proximal end and a length sufficient to position thedistal end within the bladder and to position the proximal end adjacentto and distal of the orifice in the external urinary sphincter musclewhen the catheter is in a use position.
 43. A catheter as defined inclaim 42, further comprising: an activation device connected to thecontact element and extending through the interior passageway andextendable from the main body through the orifice of the externalurinary sphincter muscle and through the urinary canal to a positionoutside of the exterior opening of the urinary canal, the activationdevice moving the contact element by manipulation of the activationdevice at the position outside the exterior opening of the urinarycanal.
 44. A catheter as defined in claim 43, further comprising incombination: an insertion tool for inserting the catheter into theurinary tract to the use position, the insertion tool having a distalend for connecting with the proximal end of the main body and a proximalend that extends to a position outside the exterior opening of theurinary canal, the insertion tool having an interior channel extendingfrom its distal end to its proximal end, the interior channelcommunicating with the interior passageway in the main body when thedistal end of the insertion tool is connected to the proximal end of themain body; and wherein: the activation device extends through theinterior channel of the insertion tool when the insertion tool isconnected to the main body.
 45. A catheter as defined in claim 42,further comprising: a balloon attached to the distal end of the mainbody, the balloon is expandable in size when inflated within the bladderto maintain the distal end of the main body in the bladder and torestrain the main body against proximal movement from the use position;and an inflation tube having a distal end, a proximal end and a lengthextending between the distal and proximal ends, the distal end of theinflation tube connected to the main body, the length of the inflationtube sufficient to extend from the main body through the orifice of theexternal urinary sphincter muscle and the urinary canal to a positionoutside of an exterior opening of the urinary canal, the inflation tubeand the main body establishing an inflation passageway extending fromthe proximal end of the inflation tube to the balloon through which todeliver fluid to inflate the balloon.
 46. A catheter as defined in claim45, further comprising: a proximal anchor connected to the proximal endof the main body and located at a position adjacent to and proximal ofthe external urinary sphincter muscle when the main body is in the useposition, the proximal anchor interacting with the external urinarysphincter muscle when constricted to restrain the main body againstdistal movement from the use position.
 47. A catheter as defined inclaim 46, wherein: the proximal anchor comprises a coiled section of theinflation tube formed at a position along the inflation tube to beadjacent to and proximal of the sphincter muscle when the main body islocated in the use position.
 48. A catheter as defined in claim 29,wherein: the contact element is retained within the interior passagewayin a stowed position at a distal end of the interior passageway; thecontact element when in the stowed position is substantially out of aurine drainage flow path through the inlet opening and the interiorpassageway; and the contact element is returned to the stowed positionafter the contact element has been moved past the inlet opening andalong the interior passageway.
 49. A method of making an urinarycatheter more resistant to obstructions from blood clots in a urineflowpath from a bladder through urinary tract, the catheter having amain body with an interior passageway for draining the urine through thecatheter and an urine inlet opening formed through the main body andinto the interior passageway at a distal end, comprising: moving a clotclearing contact element positioned within the interior passageway pastthe inlet opening and along a portion of the interior passageway tocontact and disintegrate and facilitate movement of blood clots andobstructions within the inlet opening and the interior passageway withthe flow of urine through the interior passageway.
 50. A method asdefined in claim 49, further comprising: stowing the contact element ina stowed position substantially out of the urine flow path through theinlet opening and into the interior passageway before moving the contactelement.
 51. A method as defined in claim 49, further comprising:positioning the contact element in a stowed position located at a distalend of the interior passageway before moving the contact element tocontact and disintegrate and facilitate movement of blood clots andobstructions within the inlet opening and the interior passageway.
 52. Amethod as defined in claim 49, further comprising: moving the contactelement by transferring force to the contact element through an urinarycanal of the urinary tract from a position outside of an exterioropening of the urinary canal to contact and disintegrate and facilitatemovement of blood clots and obstructions within the inlet opening andthe interior passageway.
 53. A method as defined in claim 52, furthercomprising: extending a tether connected to the contact element from thecontact element through the interior passageway and the urinary canal tothe exterior opening of the urinary canal; and pulling the tether totransfer force to move the contact element to contact and disintegrateand facilitate movement of blood clots and obstructions within the inletopening and the interior passageway.
 54. A method as defined in claim53, further comprising: removing the contact element from the interiorpassageway by continuing to pull the tether after the contact elementhas been moved to contact and disintegrate and facilitate movement ofblood clots and obstructions within the inlet opening and the interiorpassageway.
 55. A method as defined in claim 50, further comprising:returning the contact element to the stowed position after having movedthe contact element to contact and disintegrate and facilitate movementof blood clots and obstructions within the inlet opening and theinterior passageway.
 56. A method as defined in claim 49, furthercomprising: using a brush structure as the contact element to contactand disintegrate and facilitate movement of blood clots and obstructionswithin the inlet opening and the interior passageway.
 57. A method asdefined in claim 49 wherein the catheter is of the partial-lengthindwelling type used to drain urine from the bladder to a locationadjacent to an orifice in an external urinary sphincter muscle whichcontrols urine flow into a urinary canal of the urinary tract, furthercomprising: positioning the distal end of the main body within thebladder when the catheter is in a use position; and positioning aproximal end of the main body adjacent to and distal of the externalurinary sphincter muscle when the catheter is in the use position.
 58. Amethod as defined in claim 57, further comprising: moving the contactelement by transferring force to the contact element through the urinarycanal and the orifice of the external urinary sphincter muscle from theposition outside of the exterior opening of the urinary canal.
 59. Amethod as defined in claim 57, further comprising: connecting theproximal end of the main body to an insertion tool; inserting thecatheter through the urinary canal into the use position by movementimparted through the insertion tool; and extending an activation devicethrough an interior channel of the insertion tool to transfer force tothe contact element through the urinary canal and the orifice of theexternal urinary sphincter muscle from the position outside of theexterior opening of the urinary canal.
 60. A method as defined in claim57, wherein the catheter is further of the type comprising a balloonattached to the distal end of the main body and an inflation tubecommunicating with an interior of the balloon and extending from themain body through the urinary canal to the position outside of theexterior opening of the urinary canal when the catheter is in the useposition, the method further comprising: delivering fluid through theinflation passageway to inflate the balloon within the bladder andrestrain the main body against proximal movement from the use position.61. A method as defined in claim 60, further comprising: anchoring thecatheter within the urinary canal adjacent to and proximal of theexternal urinary sphincter muscle to restrain the main body againstdistal movement from the use position.
 62. A method as defined in claim60, further comprising: locating a coiled section of the inflation tubeadjacent to and proximal of the external urinary sphincter muscle torestrain the main body against distal movement from the use position.